Orange Book product · Brand (NDA)
ORENITRAM
TREPROSTINIL DIOLAMINE
At a glance
Dec 20, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 2013
12 yr 8 mo ago
Patent 9393203 expires
Listed drug product patent expiration.
Apr 27, 2026
2 mo ago
Today
Patent 7417070 expires
Listed drug substance patent expiration.
Jul 30, 2026
in 1 mo
Exclusivity ends · ODE-272
Orphan-drug exclusivity (7 years)
Oct 18, 2026
in 4 mo
Patent 11723887 expires
Listed drug substance patent expiration.
Dec 15, 2028
in 2 yr 6 mo
Patent 9593066 expires
Listed drug substance patent expiration.
Dec 15, 2028
in 2 yr 6 mo
Patent 9604901 expires
Listed drug substance patent expiration.
Dec 15, 2028
in 2 yr 6 mo
Patent 8410169 expires
Listed drug product patent expiration.
Feb 13, 2030
in 3 yr 9 mo
Patent 8349892 expires
Listed drug product patent expiration.
Jan 22, 2031
in 4 yr 8 mo
Patent 8747897 expires
Listed drug product patent expiration.
Aug 11, 2031
in 5 yr 3 mo
Patent 8747897 expires
Listed drug product patent expiration.
Aug 11, 2031
in 5 yr 3 mo
Pharmaceutical detail
Active ingredient
TREPROSTINIL DIOLAMINE
Strength
EQ 0.125MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 203496
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- ODE-272Orphan-drug exclusivity (7 years)
Oct 18, 2026
in 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9393203 | Apr 27, 2026 | 2 mo ago | ProductU-1877 |
| 7417070 | Jul 30, 2026 | in 1 mo | Substance |
| 11723887 | Dec 15, 2028 | in 2 yr 6 mo | Substance |
| 9593066 | Dec 15, 2028 | in 2 yr 6 mo | Substance |
| 9604901 | Dec 15, 2028 | in 2 yr 6 mo | SubstanceDelisted |
| 8410169 | Feb 13, 2030 | in 3 yr 9 mo | Product |
| 8349892 | Jan 22, 2031 | in 4 yr 8 mo | Product |
| 8747897 | Aug 11, 2031 | in 5 yr 3 mo | ProductU-2725 |
| 8747897 | Aug 11, 2031 | in 5 yr 3 mo | ProductU-2724 |
